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            [0] => Design and Implementation of a Traceability Procedure for Orthopedic Implantable Devices
        )

    [etablissement] => Array
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            [0] => Centre de Traumatologie et des Grands Brûlés
        )

    [nom] => Array
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            [0] => Guibene
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    [prenom] => Array
        (
            [0] => Wiem
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    [email] => Array
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            [0] => wiem.guibene@hotmail.com
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            [0] => +21699437176
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            [0] => 
 
Nom prénom: Guibene Wiem
Email: Guibene Wiem
Hôpital: Centre de Traumatologie et des Grands Brûlés

        )

    [mots_cles] => Array
        (
            [0] => Traceability, Procedure, Implantable Devices;

        )

    [event-id] => Array
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            [0] => 3663
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            [0] => 1
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    [abstract] => Array
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            [0] => https://www.sotcot.tn/wp-content/uploads/gravity_forms/1-734bfe19ec36a1528718899bf7a2927f/2024/03/Design-and-Implementation-of-a-Traceability-Procedure-for-Orthopedic-Implantable-Devices1.docx
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            [0] => wiem.guibene@hotmail.com
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    [specialite] => Array
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            [0] => Pharmacie Hospitalière
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    [pays] => Array
        (
            [0] => Tunisie
        )

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        (
            [0] => Introduction:
The health traceability of IMDs is governed by the materiovigilance framework, which establishes particular management standards outlining the stages and duties of each of the actors. The goal of the work is to secure the traceability of the entire IMD circuit in order to meet a dual requirement of Materiovigilance/Identitovigilance and Patient Documentation. 
Materials and Methods:
• Manual traceability documentation system: IMD prescription sheet, patient notebook, Operating Room OR register, traceability register, patient file traced, the ultimate label and intervention sheet. 
• IT resources: EXCEL®: Traceability module at the Internal Use Pharmacy IUP and the OR levels. DMI® stands for Computerized Medical Record. 
• Procedure for Managing Temporary Deposits: → Reservation request ANCILLARY + IMPLANTS emanating from the OR → Confirmation of reservation [IUP -Supplier] → Reception: the Ancillary →Sterilization [OR] the implant Verification [IUP] → IMD's Implementation → Registration at the OR and IUP: double traceability: 
•IT registration [OR, IUP: patient and DMI data export]  Manual registration with final label affixing verification [Bloc; PUI] 
Results:
Several notions are distinct: 
• Double traceability at the OR and IUP: IT and manual 
• Archiving 10 years or 40 years if DMI contains an MDS-like substance. 
• The Patient Document and the IMD Card 
• Communication: a multidisciplinary institutional project. Its goal is to properly and efficiently safeguard the circuit of implantable medical devices. 
• Degraded procedure: action to be taken in the case of an IMD traceability system malfunction. 
Discussion:
Several areas for improvement to minimize procedure degradation and circuit security: 
- Health traceability of IMDs on computer media produced for this purpose. 
- Traceability data entry via optical barcode reading. 
- Real-time traceability at every stage of the system via regular checks and audits of traceability data quality. 
- Traceability training for actors. 
- Incorporate a validated and up-to-date protocol on: storage or disposal conditions for explanted IMDs and delivery of the patient IMD card.
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